We, the undersigned, are organizations of people living with hepatitis C virus (HCV), HIV, and our allies. We believe in equitable access to life-saving treatment for all who need it.

An estimated 150 million people are chronically infected with hepatitis C, the vast majority in developing countries, where there is currently little to no access to treatment—because it is unaffordable. Each year, nearly 500,000 people die from HCV complications instead of being cured.

We write to express our indignation over Gilead’s pricing and licensing policies for the HCV drug, sofosbuvir. These concerns also cover your HCV drugs, ledipasvir and GS-5816. Gilead has set prices for sofosbuvir and the sofosbuvir/ledipasvir combination that are out of reach for a majority of patients worldwide. It has also strategically locked several key Indian manufacturers into licensing agreements that place tight restrictions on the generic market. These agreements reduce generic competition, especially for the 50 million people who live in low- and middle-income (LMICs) countries that are excluded from the licenses. Your decisions will artificially inflate prices, limit patient access and create barriers to HCV treatment scale-up.

It is widely acknowledged that unrestricted generic competition is the most effective strategy for reducing the price of medicines to the lowest possible sustainable levels. Sofosbuvir is unaffordable, even for high-income countries. Addressing hepatitis C requires a robust competitive generic market for in LMICs– and all other countries– to meet public health goals. Gilead’s pricing policy and voluntary licenses are incompatible with universal access.

Although much cheaper sofosbuvir is also needed in developed countries, this letter primarily addresses the negative impact of Gilead’s policies on LMICs. First, both pricing and licensing agreements exclude countries– in particular a number of LMICs with a high burden of HCV– from access to generic sofosbuvir. Instead, they must buy it from Gilead, at whatever price the company sets. Second, the licensing policy places extreme restrictions on its licensees, which prevent free and fair competition and the use of the lowest-cost raw materials. According to one analysis, Gilead’s restrictions on generic competition for sofosbuvir will increase the total cost of curing hepatitis C by an estimated $60 billion dollars. The consequence? Governments will drain much needed resources for health on one drug alone. Or worse, millions will die because governments cannot afford to purchase the drug at such high prices.

We strongly urge Gilead to immediately improve the terms of these licenses to support affordable access, and take the following steps:

Expand geographic coverage of the licenses, to include the 51 middle-income countries that are currently excluded.These countries are home to 49 million people infected with HCV, or approximately 43% of the middle-income country total. Excluding these countries—and the millions of people with hepatitis C who live in them– from the generic market for sofosbuvir means that there will be little or no access through the public health system. Countries will be forced to pay the price that Gilead sets–which will be far higher than they can afford– to treat their millions of patients in need.

Remove restrictions on producing and sourcing sofosbuvir’s active pharmaceutical ingredients (API). The cost of API is strongly linked to the cost of the final product offered by generic companies.The Gilead license only allows licensees to source API from other licensees, or with approval from Gilead’s suppliers. This severely restricts the number of potential low-cost sources for three key reasons. First, only Indian companies are eligible to be licensees for both sofosbuvir API and the finished product. Such a restriction blocks suppliers in other key countries (such as China) from supplying low-cost API. Second, the number of sofosbuvir licensees producing API remains small, thereby limiting competition amongst these suppliers to drive down prices. Competition among API producers to develop the shortest and most efficient route and increase yields will make it possible for generic companies to reduce costs and eventually meet the goal of supplying sofosbuvir at $US1 per pill. Without fierce competition among Chinese and Indian API producers and access to lower-cost sources for these materials, the price of generic sofosbuvir will remain unnecessarily high and limit the number of patients that will be able to access the product.

Modify unethical anti-diversion requirements to ensure that they do not limit patient access. Gilead is using–and is also requiring its licensees to adopt–an anti-diversion program which exceeds the typical differential packaging and quantity control measures used for this purpose. Gilead’s anti-diversion system will be enforced through local distributors and include unethical—and burdensome—requirements: patients and treatment providers may have to disclose the name, address, and other sensitive personal information to companies not directly involved in patient care, and return each empty sofosbuvir bottle to the distributor before they can get more to complete their HCV treatment. These conditions violate basic standards of patient confidentiality and autonomy, and interfere with both the doctor-patient and pharmacist-patient relation. The extra travel requirements or complex alternative pill return and re-supply systems risk interrupting patient care and may even result in default. Certain requirements—such as demonstrating proof of residence or citizenship are likely to exclude high-prevalence, marginalized populations (such as refugees and people who use and inject drugs) who lack without stable living arrangements. These requirements, individually and collectively, interfere with the human right to health and the right of access to essential medicines codified in international and national law.

While not exhaustive, this list of improvements is a necessary starting point for providing patients in all developing countries with access to affordable, generic HCV treatment.

This voluntary license demands an unacceptable trade-off. It provides access to some while excluding millions of patients from access to affordable treatment via the limited geographic scope of the license and the anti-diversion program. It ensures artificially high prices for generics, due to unreasonable restrictions on the production and procurement of the raw materials –active pharmaceutical ingredient (API)—needed to produce sofosbuvir. And it enables Gilead to violate patient privacy and interfere with medical care that should remain between a doctor and patient, through implementation of the anti-diversion program.

Gilead’s unethical pricing and restrictive licensing policies fly in the face of the company’s stated goal to increase competition and affordable access to its HCV medications. We remind Gilead that in the absence of access-friendly policies, these countries have the option of using TRIPS flexibilities including compulsory licenses, patent examination employing public health safeguards, and patent oppositions to address this urgent public health need.

We urge you to drop your appeal against the recent Indian decision that legitimately rejects one of your key patent applications for sofosbuvir. We also urge you to stop pressuring and lobbying the Indian government and patent officials to reverse this decision, and to grant patents for all of your HCV drugs that are under examination. Gilead should respect India’s legal process, not try to influence it through other channels. This goes against the democratic nature of India’s legal system, which is fair and transparent.

We strongly encourage you to take positive steps to expand, not inhibit, access to the HCV drugs sofosbuvir, ledipasvir and GS 5816.

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